Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin - Full Text View

Purpose

Primary Objective:

- To compare the efficacy of insulin glargine new formulation and lantus in terms of Change in HbA1c from baseline to endpoint (scheduled month 6)

Secondary Objectives:

- To compare the efficacy of insulin glargine new formulation and lantus in terms of occurrence of Hypoglycemia

Condition	Intervention	Phase
Type 2 Diabetes Mellitus	Drug: New formulation of insulin glargine Drug: Lantus (insulin glargine)	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	6-Month, Multicenter, Randomized, Open-label, Parallel-group Study Comparing the Efficacy and Safety of a New Formulation of Insulin Glargine and Lantus® Both Plus Mealtime Insulin in Patients With Type 2 Diabetes Mellitus With a 6-month Safety Extension Period

Resource links provided by NLM:

MedlinePlus related topics: Diabetes Diabetes Medicines Diabetes Type 2 Hypoglycemia

Drug Information available for: Insulin human Insulin glargine

U.S. FDA Resources

Further study details as provided by Sanofi:

Primary Outcome Measures:

Change from baseline in HbA1c [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Incidence of patients (%) with at least one nocturnal hypoglycemia between start of week 9 and endpoint, indicated as severe and/or confirmed by plasma glucose ≤ 70 mg/dL (3.9 mmol/L) which occurred between 0:00 and 5:59 hours [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]
Change from baseline in preinjection plasma glucose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Change from baseline in variability of preinjection plasma glucose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Percentage of patients with HbA1c < 7% at endpoint [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in fasting plasma glucose (FPG) [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Percentage of patients with FPG < 100mg/dL at endpoint [ Time Frame: 6 months ] [ Designated as safety issue: No ]
Change from baseline in 8-point self-monitored plasma glucose profile [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Change from baseline in daily basal insulin dose [ Time Frame: Baseline, 6 months ] [ Designated as safety issue: No ]
Change from baseline in treatment satisfaction score using the Diabetes Treatment Satisfaction Questionnaire (DTSQs) [ Time Frame: Baseline, up to 6 months ] [ Designated as safety issue: No ]
Number of Patients with various types of Hypoglycemia Events [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	800
Study Start Date:	December 2011
Estimated Study Completion Date:	August 2013
Primary Completion Date:	January 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: New formulation of insulin glargine once daily on top of mealtime insulin with or without metformin	Drug: New formulation of insulin glargine Pharmaceutical form:solution Route of administration: subcutaneous
Active Comparator: Lantus (insulin glargine) once daily on top of mealtime insulin with or without metformin	Drug: Lantus (insulin glargine) Pharmaceutical form:solution Route of administration: subcutaneous Other Name: Lantus

Detailed Description:

The maximum study duration will be 54 weeks per patient, consisting of:

up to 2 week screening period;
6-month comparative efficacy and safety treatment period;
6-month comparative safety extension period;
2-day safety follow-up period.
a 3-month administration substudy period starting after completion of the 6-month study period for patients willing to.

Eligibility

Criteria

Inclusion criteria :

- Patients with type 2 diabetes mellitus

Exclusion criteria:

Age <18 years;
HbA1c <7.0% or >10% at screening;
Diabetes other than type 2 diabetes mellitus;
Less than 1 year on basal plus mealtime insulin and self-monitoring of blood glucose;
Any contraindication to use of insulin glargine as defined in the national product label;
Patients using human regular insulin as mealtime insulin in the last 3 months before screening visit;
Use of an insulin pump in the last 6 months before screening visit;
Initiation of new glucose-lowering agents and/or weight loss drugs in the last 3 months before screening visit;
History or presence of significant diabetic retinopathy or macular edema likely to require laser or injectable drugs or surgical treatment during the study period;
Pregnant or breast-feeding women or women who intend to become pregnant during the study period

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01499082

Sponsors and Collaborators

Sanofi

Investigators

Study Director:

Clinical Sciences & Operations

Sanofi

More Information

No publications provided

Responsible Party:	Sanofi
ClinicalTrials.gov Identifier:	NCT01499082 History of Changes
Other Study ID Numbers:	EFC11628, 2010-023769-23
Study First Received:	December 16, 2011
Last Updated:	April 8, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Glargine

Insulin
Insulin, Long-Acting
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013

Comparison of a New Formulation of Insulin Glargine With Lantus in Patients With Type 2 Diabetes Mellitus on Basal Plus Mealtime Insulin (EDITION I)